The Blood Industry

The Blood Industry

The goal of this study on the blood industry is to describe and analyze the current markets for blood products, blood tests, and blood processing equipment as well as present important new developments affecting every aspect of this industry. In addition, the report provides an analysis of market value forecasted through 2012 in constant dollars and participating company profiles. The study covers the major aspects of blood and plasma collection/transfusion, including autologous donations, apheresis, fractionation, blood salvage, and stem cells. The major plasma products such as coagulation factors, human serum albumin, and immunoglobulins are analyzed as well. The scope and character of the blood testing segment is constantly changing so the impact of new products, technologies, and equipment are analyzed.

The study also covers federal regulation of the blood supply, blood system management, an analysis of the companies serving these markets, the international developments in blood banking, and related areas as well as research and patents that will affect the future of the blood industry.  
 

INTRODUCTION

STUDY GOAL AND OBJECTIVES

REASONS FOR DOING THIS STUDY

INTENDED READERSHIP

SCOPE OF REPORT

METHODOLOGY AND INFORMATION SOURCES

ANALYST’S CREDENTIALS

RELATED BCC REPORTS

BCC ONLINE SERVICES

DISCLAIMER

SUMMARY

MAJOR FINDINGS

SUMMARY TABLE U.S. BLOOD MARKET, THROUGH 2012 ($ MILLIONS)

SUMMARY FIGURE U.S. BLOOD MARKET, 2007 AND 2012 ($ MILLIONS)

OVERVIEW

THE BLOOD INDUSTRY

MARKET STRUCTURE AND SIZE

TABLE 1 U.S. BLOOD PRODUCTS AND COLLECTION AND PROCESSING PRODUCTS MARKET, THROUGH 2012 ($ MILLIONS)

HISTORY OF THE BLOOD INDUSTRY

TABLE 2 TIMELINE OF THE BLOOD INDUSTRY

TABLE 2 (CONTINUED)

BLOOD AND ITS COMPONENTS

PLASMA

TABLE 3 COMPOSITION OF BLOOD

CELLULAR ELEMENTS

Red and White Blood Cells

Platelets

IMMUNOGLOBULIN PRODUCTS

THE DANGERS OF TRANSFUSED BLOOD

TRANSFUSION ASSOCIATED RISKS

Diseases Contracted from Blood Transfusions and Related

Identification Testing

TABLE 4 MAJOR DISEASES CONTRACTED FROM BLOOD TRANSFUSIONS

TABLE 4 (CONTINUED)

HIV/AIDS

TABLE 5 CBER-LICENSED HIV DONOR SCREENING TESTS

TABLE 5 (CONTINUED)

Hepatitis A

Hepatitis B

TABLE 6 CBER-LICENSED SCREENING TESTS FOR HEPATITIS B

Hepatitis C

TABLE 7 CBER-LICENSED SCREENING TESTS FOR HEPATITIS C

Hepatitis D

Hepatitis E

Human T Cell Lymphotropic Virus—(HTLV-I, -II)

TABLE 8 CBER-LICENSED SCREENING TESTS FOR HTLV-I AND HTLV-II

Cytomegalovirus

TABLE 9 CBER-LICENSED SCREENING TESTS FOR CMV

TABLE 9 (CONTINUED)

TABLE 10 CBER-LICENSED SCREENING TESTS FOR WEST NILE

“Mad Cow Disease”—Creutzfeldt-Jakob Disease

(CJD)

Syphilis

Chagas Disease

Chagas Disease (Continued)

Current Status of Blood Donor Screening for

Chagas Disease

EFFORTS TO CREATE A VIRUS-FREE BLOOD SUPPLY

Plasma Treatments

Trinitrobutyl Phosphate and Sodium Cholate

Methylene Blue-treated Plasma

Amatosalen HCL—Treated Plasma

Platelet Treatments

RBCs

NEGATIVE REACTIONS FROM BLOOD TRANSFUSIONS

Negative Reactions from Blood … (Continued)

BLOOD/PLASMA COMPONENT RISKS

THE BLOOD MANAGEMENT SYSTEM: BLOOD COLLECTION, PROCESSING, AND USE

BLOOD COLLECTION

ORGANIZATIONS COLLECTING BLOOD

For-profit Blood Collection

Plasma Collection Centers

National Donor Deferral Registry

Nonprofit Blood Collection

American Red Cross

Community Blood Banks

Hospitals

Other Blood Collection Sites

BLOOD DONATION DEMOGRAPHICS

DONOR RECRUITMENT AND REGULATIONS

BLOOD SCREENING AND EVALUATION

METHODS FOR COLLECTING BLOOD FROM A DONOR

Manual Collection

Automated Collection

Plasmapheresis

Plateletpheresis

Leukopheresis

Red Blood Cell Apheresis

PLASMA COLLECTION

Commercial Nature of Plasmapheresis

Global Nature of the Plasma Industry

Plasma Fractionators

Distributors/Brokers

BLOOD TYPING AND TESTING FOR DISEASES

Blood Typing

TABLE 11 TESTS ROUTINELY PERFORMED ON BLOOD DONATIONS

TABLE 11 (CONTINUED)

TABLE 12 BLOOD TYPE ANTIGEN/ANTIBODY REACTIONS

Methods of Typing

Manual Blood Typing Methods

Slide/Tile Testing

Tube Testing

Microplate

Automated Blood Typing and Screening Methods

Blood Testing

Blood Storage

BLOOD PROCESSING

Preparation and Use of the Components

Red Blood Cell Components

Platelets

BLOOD TRANSFUSIONS

Testing before Transfusion

Manual Crossmatch Techniques

Major Crossmatch

Minor Crossmatch

Antibody Screen

Coombs Test

TYPES OF TRANSFUSIONS

Whole Blood

Packed Red Blood Cells

Platelets

Leukocytes

Fresh Frozen Plasma (FFP)

TABLE 13 SELECTED USES OF FFP

Cryoprecipitate

Coagulation Factors

TABLE 14 LISTING OF BLOOD PRODUCTS FOR THERAPEUTIC USE

Immune Serum Globulin/Intramuscular Immune

Globulins (IMIG)/Intravenous Immune Globulin

(IGIV)

Factor VIII

Factor IX and Factor IX Complex

Factor VIIa

Fibrin/Thrombin

Therapeutic Apheresis

BLOOD MANAGEMENT ISSUES

AVAILABILITY ISSUES

BLOODLESS SURGERY

SAFETY ISSUES—RISK MANAGEMENT

TABLE 15 FACTORS TO REDUCE RISKS OF TRANSFUSIONASSOCIATED DISEASES

Better Donor Screening

Better Viral Screening Tests

Get More Repeat Donors

Develop Better Viral Inactivation Processes

Selective Use of Blood Derivative Products

REGULATION OF THE BLOOD BUSINESS

REGULATION OF THE U.S. BLOOD BUSINESS

TABLE 16 FEDERAL ORGANIZATIONS RESPONSIBLE FOR U.S. BLOOD SAFETY

TABLE 16 (CONTINUED)

STATUTORY AUTHORITY OF THE FDA

Center for Biologics Evaluation and Research

Office of Regulatory Affairs (ORA)

Office of Biologics, the Division of Blood and Blood

Products

TABLE 17 FDA AUTHORITY IN REGULATING BLOOD BANKING AND BLOOD PRODUCTS

THE MAJOR REGULATIONS AND POLICY MATTERS

CONCERNING THE U.S.BLOOD SUPPLY

The Clinical Laboratory Improvement Act of 1988 (CLIA)

The FDA’S Five Layers

The FDA Blood Action Plan

TABLE 18 MAIN BLOOD REGULATION ISSUES IDENTIFIED BY THE FDA

TABLE 18 (CONTINUED)

Team Biologics

HOW REGULATIONS GET IMPLEMENTED

Inspecting Blood Banks and Plasma Collection Facilities

TABLE 19 14 MAJOR AREAS OF CONCERN FOR INSPECTING BLOOD FACILITIES

OTHER ORGANIZATIONS INVOLVED IN BLOOD

REGULATION

National Heart, Lung, and Blood Institute (NHLBI)

Blood Diseases and Resources Program

Occupational Safety and Health Administration (OSHA)

Health Care Financing Administration (HCFA)

The Department of Defense

State Regulatory Agencies

VOLUNTARY REGULATION BY PROFESSIONAL AND TRADE ASSOCIATIONS

American Association of Blood Banks

American Blood Resources Association

America’s Blood Centers (ABC)

PPTA: Plasma Products Therapeutics Association

THE EUROPEAN UNION (EU) BLOOD DIRECTIVE

International Society for Blood Transfusion (ISBT) 128

THE FUTURE OF BLOOD REGULATION

THE BLOOD AND BLOOD PRODUCTS MARKET

DRIVING FORCES OF THE INDUSTRY

FIGURE 1 VARIABLES INFLUENCING THE DYNAMICS OF DEMAND FOR BLOOD FOR TRANSFUSION

MARKET OVERVIEW

FIGURE 2 BLOOD MARKET COST AND PRICING ANALYSIS BLOOD COLLECTION DATA

TABLE 20 U.S. BLOOD COLLECTION AND TRANSFUSION DATA, THROUGH 2012 (MILLION UNITS/PTS.)

FIGURE 3 U.S. BLOOD COLLECTION AND TRANSFUSION DATA, 2005-2012 (MILLION UNITS/PTS.)

TABLE 21 U.S. PLASMA COLLECTION DATA, THROUGH 2012 (MILLION UNITS/L)

FIGURE 4 U.S. PLASMA COLLECTION DATA, 2005-2012 (MILLION UNITS/L)

CHANGING PATTERNS OF TRANSFUSION PROCEDURES

Leukoreduction

Impact of Autologous Donations

Types of Autologous Transfusions

Risks of PABD

PRICING OF BLOOD

TABLE 22 COST OF BLOOD COMPONENTS, THROUGH 2012 ($)

National Blood Exchange (NBE)

RBCs and Leukoreduced RBCs

Platelets

Random Donor Platelets

Fresh Frozen Plasma (FFP)

Cryoprecipitate

Washed Cells

Deglycerolized Cells

Other Blood Components

Granulocytes

Gamma-Irradiated Blood

AVERAGE COST OF TRANSFUSION

TABLE 23 AVERAGE COST OF TRANSFUSION TO PATIENT BY PRODUCT TYPE, 2007 ($)

PLASMA AND PLASMA-DERIVED PRODUCTS

Plasma Market Size

Plasma Therapeutic Products

TABLE 24 U.S. MARKET SIZE PLASMA THERAPEUTIC DERIVATIVES BY TYPE, THROUGH 2012 ($ MILLIONS)

FIGURE 5 SHARE OF PLASMA THERAPEUTIC DERIVATIVES BY TYPE, 2007 AND 2012 (%)

Albumin and Plasma Protein Fraction (PPF)

FDA Notification Regarding Safety of

Albumin Administration in Critically Ill

Recombinant Human Albumin

Albumin Market Dynamics

TABLE 25 CURRENTLY MARKETED ALBUMIN AND PLASMA

PROTEIN FRACTION (PPF) PRODUCTS

Albumin and PPF Market Size

TABLE 26 U.S. MARKET FOR HUMAN SERUM ALBUMIN AND PPF, THROUGH 2012 (UNITS, PRICE, AND VALUE)

Clotting Factors

TABLE 27 BLOOD CLOTTING FACTORS

Hemophilia

TABLE 28 WORLDWIDE AND U.S.HEMOPHILIA STATISTICS, 2007

Market Demand and Market Size

TABLE 29 U.S. MARKET FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING FACTORS, THROUGH 2012 ($ MILLIONS)

FIGURE 6 U.S. SHARE FOR PLASMA-DERIVED AND RECOMBINANT CLOTTING FACTORS, 2007 AND 2012 (%)

Factor VIII

TABLE 30 FDA-APPROVED FACTOR VIII PRODUCTS

TABLE 30 (CONTINUED)

Factor VIII (Continued)

TABLE 31 U.S. MARKET SHARE FACTOR VIII COMPANIES, 2007

FIGURE 7 MARKET SHARE OF FACTOR VIII COMPANIES, 2007 (%)

Factor IX

TABLE 32 FDA-APPROVED FACTOR IX PRODUCTS

Factor VIIa

Other Factors

Prothrombin Complex Concentrates

TABLE 33 FDA-APPROVED PROTHROMBIN COMPLEX CONCENTRATE PRODUCTS

Fibrin Sealants and Thrombin

TABLE 34 U.S. MARKET FOR FIBRIN/THROMBIN, THROUGH 2012 ($ MILLIONS)

Antithrombin III

TABLE 35 U.S. MARKET FOR ANTITHROMBIN III—THROMBATE, THROUGH 2012 ($ MILLIONS)

Immunoglobulins

IVIG

TABLE 36 SELECTED CONDITIONS TREATED BY IVIG

TABLE 37 FDA-APPROVED IMMUNOGLOBULINS

Hyperimmunes

TABLE 38 FDA-APPROVED HYPERIMMUNE IMMUNOGLOBULINS

TABLE 38 (CONTINUED)

Other

IMIG

Immunoglobulin Market Size

TABLE 39 U.S. MARKET FOR IMMUNOGLOBULINS BY TYPE, THROUGH 2012 ($ MILLIONS)

FIGURE 8 U.S. MARKET FOR IMMUNOGLOBULINS BY TYPE, 2007 AND 2012 ($ MILLIONS)

RSV

CMV Immunoglobulin

Hepatitis B Immune Globulin

RhoD Immunoglobulin

Tetanus Immunoglobulin (TIG)

Rabies Immunoglobulin

Varicella Immunoglobulin

Vaccinia Immune Globulin Intravenous (VIG)

Alpha-1-Proteinase Inhibitor

Alpha-1-Proteinase (Continued)

BLOOD TESTING AND TYPING MARKETS

MARKET SIZE

TABLE 40 VALUE U.S. BLOOD TYPING AND BLOOD SCREENING MARKET, THROUGH 2012 ($ MILLIONS)

FIGURE 9 VALUE AND MARKET SHARE OF U.S. BLOOD TYPING AND BLOOD SCREENING MARKET, 2007 AND 2012 (%)

TYPES OF TESTING

POLYMERASE CHAIN REACTION (PCR) AMPLIFICATION

TABLE 41 CBER-LICENSED PCR SCREENING TESTS

TABLE 41 (CONTINUED)

NUCLEIC ACID AMPLIFICATION TEST (NAT)

TABLE 42 CBER-LICENSED NAT DONOR SCREENING TESTS

IMMUNOASSAY

TABLE 43 IMMUNOASSAY CBER-LICENSED SCREENING TESTS

TABLE 43 (CONTINUED)

MARKET SIZE BLOOD TESTING PRODUCTS FOR DONOR

SCREENING

TABLE 44 AVERAGE COST OF DONOR BLOOD TESTING, 2007 AND 2012 ($ MILLIONS)

TABLE 45 THE U.S. BLOOD DONOR SCREENING TESTING MARKET BY TYPE OF TESTS, THROUGH 2012 ($ MILLIONS)

FIGURE 10 U.S. BLOOD DONOR SCREENING TESTING MARKET BY TYPE, 2007 AND 2012 ($ MILLIONS)

MARKET PARTICIPANTS DONOR SCREENING PRODUCTS

TABLE 46 LIST OF SUPPLIERS DONOR SCREENING TESTS

BLOOD TYPING

MARKET SIZE BLOOD TYPING

TABLE 47 THE U.S. BLOOD TYPING MARKET—INSTRUMENTS AND SUPPLIES BY TYPE, THROUGH 2012 ($ MILLIONS)

MARKET STRUCTURE AND PARTICIPANTS

Manual Typing Methods

Automated Blood Typing

Immucor

Ortho

Olympus

BLOOD COLLECTION/TRANSFUSION PRODUCTS AND PROCESSING EQUIPMENT AND SUPPLIES

TABLE 48 U.S. MARKET FOR BLOOD AND PLASMA COLLECTION/TRANSFUSION PRODUCTS, THROUGH 2012 ($ MILLIONS)

COLLECTION PRODUCTS

TABLE 49 U.S. MARKET FOR COLLECTION PRODUCTS BY TYPE, THROUGH 2012 ($ MILLIONS)

PLASMA AND BLOOD COLLECTION EQUIPMENT

TABLE 50 U.S. MARKET FOR BLOOD AND PLASMA COLLECTION EQUIPMENT BY TYPE, THROUGH 2012 ($ MILLIONS)

FIGURE 11 SHARE OF U.S. MARKET FOR BLOOD AND PLASMA COLLECTION PRODUCTS BY TYPE, 2007 AND 2012 (%)

Blood Salvage

OTHER COLLECTION EQUIPMENT

TABLE 51 U.S. MARKET FOR OTHER PLASMA COLLECTION PRODUCTS, THROUGH 2012 ($ MILLIONS)

MARKET PARTICIPANTS

Haemonetics

PCS2

TCD Total Containment Unit

MCS+ 8150 System

Cell Saver System

OrthoPAT System

ACP 215 System

Baxter

Autopheresis-C

Alyx Component Collection System

CS-3000 Plus Blood Cell Separator

Amicus Separator

Gambro BCT

PLASMA COLLECTION SETS

TABLE 52 U.S. MARKET FOR PLASMA COLLECTION SETS, THROUGH 2012 ($ MILLIONS)

BLOOD BAGS

TABLE 53 U.S. MARKET FOR BLOOD BAGS, THROUGH 2012 ($ MILLIONS)

TRANSFUSION PRODUCTS

TABLE 54 U.S. MARKET FOR TRANSFUSION PRODUCTS BY TYPE, THROUGH 2012 ($ MILLIONS)

Transfusion Sets

TABLE 55 U.S. MARKET FOR TRANSFUSION SETS, THROUGH 2012 ($ MILLIONS)

Blood Filter Market

TABLE 56 U.S. MARKET FOR FILTERS, THROUGH 2012 ($ MILLIONS)

Accessories

TABLE 57 U.S. MARKET FOR TRANSFUSION ACCESSORIES, THROUGH 2012 ($ MILLIONS)

TECHNOLOGY

CLASSICAL FRACTIONATION METHODS

COHN FRACTIONATION

ADVANCED FRACTIONATION METHODS

AMPLIFICATION METHODS

POLYMERASE CHAIN REACTION (PCR)

NUCLEIC AMPLIFICATION TECHNOLOGY (NAT)

IMMUNOASSAY

ENZYME IMMUNOASSAY (EIA)

Basic EIA

FIGURE 12 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS

Alternate EIA Methods

Second Antibody Precipitation Method

Double Antibody Sandwich Method

Reverse Sandwich Method

Reverse Sandwich Inhibition Method

Reverse Sandwich … (Continued)

BLOOD INDUSTRY: INTERNATIONAL ANALYSIS

GLOBAL MARKETS FOR WHOLE BLOOD COLLECTIONS

LOCAL EFFORTS AND IMPROVEMENTS

South America

Asia

Cuba

India

Pacific Region

Australia

New Zealand

Africa

South Africa

Canada

Europe

Austria

Britain

France

Germany

Italy

Switzerland

Turkey

Russia

GLOBAL MARKETS FOR SOURCE PLASMA COLLECTIONS

TABLE 58 PROJECTED GLOBAL (U.S. AND OTHER MARKETS) PLASMA COLLECTIONS, THROUGH 2012 ($ BILLIONS, MILLIONS LITERS)

GLOBAL MARKETS FOR BLOOD THERAPEUTICS

TABLE 59 PROJECTED WORLD (U.S. AND OTHER MARKETS) SALES OF PLASMA PRODUCTS*, THROUGH 2012 ($ BILLIONS)

GLOBAL MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS

TABLE 60 PROJECTED GLOBAL (U.S. AND OTHER) MARKETS FOR BLOOD TYPING AND SCREENING PRODUCTS, THROUGH 2012 ($ MILLIONS)

GLOBAL MARKETS FOR BLOOD PROCESSING EQUIPMENT AND ASSOCIATED PRODUCTS

TABLE 61 PROJECTED WORLD SALES OF BLOOD COLLECTION AND PROCESSING EQUIPMENT AND CONSUMABLES, THROUGH 2012 ($ MILLIONS)

BLOOD RESEARCH AND DEVELOPMENT

DEDICATED BLOOD RESEARCH FACILITIES

JEROME H. HOLLAND LABORATORY (ARC)

NATIONAL BLOOD FOUNDATION (NBF)

CENTER FOR BLOOD RESEARCH (CBR)

Center for Blood Research (CBR)…(Continued)

Center for Blood Research (CBR)…(Continued)

Center for Blood Research (CBR)…(Continued)

TABLE 62 SELECTED ADVANCES IN ADULT STEM CELL THERAPIES

TABLE 62 (CONTINUED)

BLOOD SUBSTITUTES

BLOOD SUBSTITUTES (CONTINUED)

FIBRIN SEALANT

THE VETERINARY BLOOD MARKET

TABLE 63 REGIONAL VETERINARY BLOOD BANKS

THE VETERINARY BLOOD MARKET (CONTINUED)

COMPANY PROFILES

ABBOTT LABORATORIES

AMERICA’S BLOOD CENTERS

AMERICAN ASSOCIATION OF BLOOD BANKS (AABB)

AMERICAN RED CROSS (ARC)

BAXTER INTERNATIONAL, INC.

BIO-RAD LABORATORIES

CSL BEHRING

GRIFOLS BIOLOGICALS, INC

GRIFOLS BIOLOGICALS, INC. (CONTINUED)

HAEMONETICS, INC.

IMMUCOR

MASSACHUSETTS PUBLIC HEALTH BIOLOGIC LABS

MEDIMMUNE CORPORATION

ORTHO-CLINICAL DIAGNOSTICS

OLYMPUS DIAGNOSTIC SYSTEMS

TALECRIS BIOTHERAPEUTICS

PATENT ANALYSIS

TABLE 64 RECENTLY ISSUED PATENTS

TABLE 65 PATENTS BY COMPANY ASSIGNEE

TABLE 65 (CONTINUED)

APPENDIX

PATENTS

BLOOD TRANSFUSIONS—11 PATENTS

Blood Transfusions—11 Patents /Continued)

Blood Transfusions—11 Patents /Continued)

Blood Transfusions—11 Patents /Continued)

Blood Transfusions—11 Patents /Continued)

BLOOD DERIVATIVES—(SEPTEMBER 1986 TO PRESENT)—

SEVEN PATENTS

Blood Derivatives…(Continued)

Blood Derivatives…(Continued)

Blood Derivatives…(Continued)

NUCLEIC ACID AMPLIFICATION (MARCH 2000 TO

PRESENT) — 40 PATENTS

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

Nucleic Acid Amplification…(Continued)

FDA-LICENSED SOURCE PLASMA FACILITIES

FDA-LICENSED SOURCE PLASMA … (CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

FDA-LICENSED SOURCE PLASMA …(CONTINUED)

GUIDANCE FOR INDUSTRY RECOGNITION AND USE OF A STANDARD FOR THE UNIFORM LABELING OF BLOOD AND BLOOD COMPONENTS

INTRODUCTION

BACKGROUND

FDA REVIEW AND CONCLUSIONS

REPORTING REQUIREMENTS FOR LICENSED

ESTABLISHMENTS

SUMMARY

LIST OF TABLES

SUMMARY TABLE U.S. BLOOD MARKET, THROUGH 2012

($ MILLIONS)

TABLE 1 U.S. BLOOD PRODUCTS AND COLLECTION AND

PROCESSING PRODUCTS MARKET, THROUGH 2012 ($ MILLIONS)

TABLE 2 TIMELINE OF THE BLOOD INDUSTRY

TABLE 3 COMPOSITION OF BLOOD

TABLE 4 MAJOR DISEASES CONTRACTED FROM BLOOD

TRANSFUSIONS

TABLE 5 CBER-LICENSED HIV DONOR SCREENING TESTS

TABLE 6 CBER-LICENSED SCREENING TESTS FOR HEPATITIS B

TABLE 7 CBER-LICENSED SCREENING TESTS FOR HEPATITIS C

TABLE 8 CBER-LICENSED SCREENING TESTS FOR HTLV-I AND

HTLV-II

TABLE 9 CBER-LICENSED SCREENING TESTS FOR CMV

TABLE 10 CBER-LICENSED SCREENING TESTS FOR WEST NILE

TABLE 11 TESTS ROUTINELY PERFORMED ON BLOOD DONATIONS

TABLE 12 BLOOD TYPE ANTIGEN/ANTIBODY REACTIONS

TABLE 13 SELECTED USES OF FFP

TABLE 14 LISTING OF BLOOD PRODUCTS FOR THERAPEUTIC USE

TABLE 15 FACTORS TO REDUCE RISKS OF TRANSFUSIONASSOCIATED

DISEASES

TABLE 16 FEDERAL ORGANIZATIONS RESPONSIBLE FOR U.S.

BLOOD SAFETY

TABLE 17 FDA AUTHORITY IN REGULATING BLOOD BANKING AND

BLOOD PRODUCTS

TABLE 18 MAIN BLOOD REGULATION ISSUES IDENTIFIED BY THE

FDA

TABLE 19 14 MAJOR AREAS OF CONCERN FOR INSPECTING BLOOD

FACILITIES

TABLE 20 U.S. BLOOD COLLECTION AND TRANSFUSION DATA,

THROUGH 2012 (MILLION UNITS/PTS.)

TABLE 21 U.S. PLASMA COLLECTION DATA, THROUGH 2012

(MILLION UNITS/L)

TABLE 22 COST OF BLOOD COMPONENTS, THROUGH 2012 ($)

TABLE 23 AVERAGE COST OF TRANSFUSION TO PATIENT BY

PRODUCT TYPE, 2007 ($)

TABLE 24 U.S. MARKET SIZE PLASMA THERAPEUTIC DERIVATIVES

BY TYPE, THROUGH 2012 ($ MILLIONS)

TABLE 25 CURRENTLY MARKETED ALBUMIN AND PLASMA PROTEIN

FRACTION (PPF) PRODUCTS

TABLE 26 U.S. MARKET FOR HUMAN SERUM ALBUMIN AND PPF,

THROUGH 2012 (UNITS, PRICE, AND VALUE)

TABLE 27 BLOOD CLOTTING FACTORS

TABLE 28 WORLDWIDE AND U.S.HEMOPHILIA STATISTICS, 2007

TABLE 29 U.S. MARKET FOR PLASMA-DERIVED AND RECOMBINANT

CLOTTING FACTORS, THROUGH 2012 ($ MILLIONS)

TABLE 30 FDA-APPROVED FACTOR VIII PRODUCTS

TABLE 31 U.S. MARKET SHARE FACTOR VIII COMPANIES, 2007

TABLE 32 FDA-APPROVED FACTOR IX PRODUCTS

TABLE 33 FDA-APPROVED PROTHROMBIN COMPLEX CONCENTRATE

PRODUCTS

TABLE 34 U.S. MARKET FOR FIBRIN/THROMBIN, THROUGH 2012

($ MILLIONS)

TABLE 35 U.S. MARKET FOR ANTITHROMBIN III—THROMBATE,

THROUGH 2012 ($ MILLIONS)

TABLE 36 SELECTED CONDITIONS TREATED BY IVIG

TABLE 37 FDA-APPROVED IMMUNOGLOBULINS

TABLE 38 FDA-APPROVED HYPERIMMUNE IMMUNOGLOBULINS

TABLE 39 U.S. MARKET FOR IMMUNOGLOBULINS BY TYPE,

THROUGH 2012 ($ MILLIONS)

TABLE 40 VALUE U.S. BLOOD TYPING AND BLOOD SCREENING

MARKET, THROUGH 2012 ($ MILLIONS)

TABLE 41 CBER-LICENSED PCR SCREENING TESTS

TABLE 42 CBER-LICENSED NAT DONOR SCREENING TESTS

TABLE 43 IMMUNOASSAY CBER-LICENSED SCREENING TESTS

TABLE 44 AVERAGE COST OF DONOR BLOOD TESTING, 2007 AND

2012 ($ MILLIONS)

TABLE 45 THE U.S. BLOOD DONOR SCREENING TESTING MARKET

BY TYPE OF TESTS, THROUGH 2012 ($ MILLIONS)

TABLE 46 LIST OF SUPPLIERS DONOR SCREENING TESTS

TABLE 47 THE U.S. BLOOD TYPING MARKET—INSTRUMENTS AND

SUPPLIES BY TYPE, THROUGH 2012 ($ MILLIONS)

TABLE 48 U.S. MARKET FOR BLOOD AND PLASMA

COLLECTION/TRANSFUSION PRODUCTS, THROUGH 2012

($ MILLIONS)

TABLE 49 U.S. MARKET FOR COLLECTION PRODUCTS BY

TYPE, THROUGH 2012 ($ MILLIONS)

TABLE 50 U.S. MARKET FOR BLOOD AND PLASMA

COLLECTION EQUIPMENT BY TYPE, THROUGH 2012

($ MILLIONS)

TABLE 51 U.S. MARKET FOR OTHER PLASMA COLLECTION

PRODUCTS, THROUGH 2012 ($ MILLIONS)

TABLE 52 U.S. MARKET FOR PLASMA COLLECTION SETS, THROUGH

2012 ($ MILLIONS)

TABLE 53 U.S. MARKET FOR BLOOD BAGS, THROUGH 2012

($ MILLIONS)

TABLE 54 U.S. MARKET FOR TRANSFUSION PRODUCTS BY TYPE,

THROUGH 2012 ($ MILLIONS)

TABLE 55 U.S. MARKET FOR TRANSFUSION SETS, THROUGH 2012

($ MILLIONS)

TABLE 56 U.S. MARKET FOR FILTERS, THROUGH 2012 ($ MILLIONS)

TABLE 57 U.S. MARKET FOR TRANSFUSION ACCESSORIES,

THROUGH 2012 ($ MILLIONS)

TABLE 58 PROJECTED GLOBAL (U.S. AND OTHER MARKETS)

PLASMA COLLECTIONS, THROUGH 2012 ($ BILLIONS, MILLIONS

LITERS)

TABLE 59 PROJECTED WORLD (U.S. AND OTHER MARKETS) SALES

OF PLASMA PRODUCTS*, THROUGH 2012 ($ BILLIONS)

TABLE 60 PROJECTED GLOBAL (U.S. AND OTHER) MARKETS FOR

BLOOD TYPING AND SCREENING PRODUCTS, THROUGH 2012

($ MILLIONS)

TABLE 61 PROJECTED WORLD SALES OF BLOOD COLLECTION AND

PROCESSING EQUIPMENT AND CONSUMABLES, THROUGH 2012

($ MILLIONS)

TABLE 62 SELECTED ADVANCES IN ADULT STEM CELL THERAPIES

TABLE 63 REGIONAL VETERINARY BLOOD BANKS

TABLE 64 RECENTLY ISSUED PATENTS

TABLE 65 PATENTS BY COMPANY ASSIGNEE

LIST OF FIGURES

SUMMARY FIGURE U.S. BLOOD MARKET, 2007 AND 2012

($ MILLIONS)

FIGURE 1 VARIABLES INFLUENCING THE DYNAMICS OF DEMAND

FOR BLOOD FOR TRANSFUSION

FIGURE 2 BLOOD MARKET COST AND PRICING ANALYSIS

FIGURE 3 U.S. BLOOD COLLECTION AND TRANSFUSION DATA, 2005-

2012 (MILLION UNITS/PTS.)

FIGURE 4 U.S. PLASMA COLLECTION DATA, 2005-2012 (MILLION

UNITS/L)

FIGURE 5 SHARE OF PLASMA THERAPEUTIC DERIVATIVES BY TYPE,

2007 AND 2012 (%)

FIGURE 6 U.S. SHARE FOR PLASMA-DERIVED AND RECOMBINANT

CLOTTING FACTORS, 2007 AND 2012 (%)

FIGURE 7 MARKET SHARE OF FACTOR VIII COMPANIES, 2007 (%)

FIGURE 8 U.S. MARKET FOR IMMUNOGLOBULINS BY TYPE, 2007

AND 2012 ($ MILLIONS)

FIGURE 9 VALUE AND MARKET SHARE OF U.S. BLOOD TYPING AND

BLOOD SCREENING MARKET, 2007 AND 2012 (%)

FIGURE 10 U.S. BLOOD DONOR SCREENING TESTING MARKET BY

TYPE, 2007 AND 2012 ($ MILLIONS)

FIGURE 11 SHARE OF U.S. MARKET FOR BLOOD AND PLASMA

COLLECTION PRODUCTS BY TYPE, 2007 AND 2012 (%)

FIGURE 12 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS